Reducing Intensive Care Unit (ICU) Related Anxiety Through a Structured Information Program

Heart Diseases Clinical Trial

Official title:

Reducing ICU Related Anxiety Through a Structured Information Program. A Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00151554
• Other study ID #: PflegeverbundMarburg2
• Secondary ID: BMBF grant 01GT0
• Status: Completed
• Phase: N/A
• First received: September 7, 2005
• Last updated: July 28, 2010
• Start date: February 2005
• Est. completion date: December 2006

Study information

• Verified date: July 2010
• Source: Philipps University Marburg Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

According to current evidence and psychological theorizing, the provision of information seems to be a promising way to reduce the anxiety of patients that is related to their scheduled ICU stay. An ICU-specific information program will be investigated in a randomized controlled clinical trial involving 120 patients undergoing elective open heart surgery and 20 patients undergoing abdominal surgery. It is expected that the patients in the test group will experience less anxiety and ICU related discomfort than patients in the control group.

Description:

Objective: According to current evidence and psychological theorizing the provision of information seems to be a promising way to reduce anxiety of patients. In the case of surgical patients, admission to the intensive care unit (ICU) is strongly associated with uncertainty, unpredictability and anxiety for the patient. Thus, ICU-specific information could have a high clinical impact. For this reason this study will evaluate the efficacy of an ICU-specific information program for patients who undergo elective cardiac, abdominal or thoracic surgery and are scheduled for ICU stay.

Methods: The trial is designed as a prospective randomized controlled trial including an intervention and a control group. The control group receives the standard preparation currently conducted by surgeons and anesthesists. The intervention group additionally receives a standardized information program with specific procedural, sensory and coping information about the ICU. In addition the moderating effect of certain personality characteristics (need for cognition, high trait anxiety) will be investigated to identify groups of patients who benefit most from the information program.

Expected Results: A clinically relevant difference in anxiety and unpleasant experiences related to the ICU is expected after discharge from the ICU. Power calculation (alpha = 0.05; beta = 0.20; delta = 8.50 score points) resulted in a required sample size of N = 120 cardiac surgical patients (n = 60 vs. n = 60). Furthermore, N = 20 abdominal or thoracic surgical patients will be recruited (n = 10 vs. n = 10).

Conclusion: The proposed study promises to strengthen evidence on the effects of a specific, concise information program and thus should contribute to evidence based nursing (EBN).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: December 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Elective open heart or abdominal surgery including scheduled ICU stay

• Informed consent

Exclusion Criteria:

• Elective surgery without ICU stay

• Informed consent denied

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Heart Diseases

Intervention

Behavioral:
• ICU-specific information program
The intervention group receives a standardized information program with specific procedural, sensory and coping information about the ICU in addition to standard information given by surgeons and anesthetists.

Locations

Country	Name	City	State
Germany	University Hospital Marburg	Marburg	Hessen

Sponsors (6)

Lead Sponsor	Collaborator
Philipps University Marburg Medical Center	Institut für Theoretische Chirurgie, Klinik für Herzchirurgie, Klinik für VTG-Chirurgie, Pflegeverbund Mitte-Süd, Stabstelle Pflegeforschung

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Berg A, Fleischer S, Koller M, Neubert TR. Preoperative information for ICU patients to reduce anxiety during and after the ICU-stay: protocol of a randomized controlled trial [NCT00151554]. BMC Nurs. 2006 Mar 8;5:4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient self-reported anxiety		after admission on standard ward	No
Primary	ICU related discomfort		after admission on standard ward	No
Secondary	Objective health status parameters		postoperative phase of hospital stay	No
Secondary	Overall satisfaction with care		3 months after discharge	No
Secondary	Quality of life		3 months after discharge	No